Recall Z-0292-2024 ยท JAK System, X-Ray, Tomography, Computed
Philips North America Llc
Big Bore RT with software version V4.8.0.10421- Model: 728242 CT scanner and simulator designed for radiation oncology and therapy.
| Date | Nov 14, 2023 (initiated Oct 9, 2023) |
| Status | Open, Classified |
| Reason | For oncology users: If the user performed off-set reconstruction on CT device a shift could be observed on the contouring area of the primary and secondary images sets when using image fusion (on TPS) and incorrect coordinates may be sent to TPS system when using absolute patient marking. This may lead to incorrect radiation therapy planning and possible growth or spread of cancer due to incorrect early treatment regimen. For radiology users: If the user performed off-set reconstruction on CT devices, after multiple acquisitions, the Relate Position could be inaccurate. This could lead to inc |
| Root cause | Under Investigation by firm |
| Action | Philips issued URGENT Medical Device Correction letter (UMDC) 2023-PD-CTAMI-015) dated 10/9/23. Letter states reason for recall, health risk and action to take: Below are short-term precautions to take until the permanent solution is installed. Enable the Force X/Y to 0/0 option on your device (Refer to the Instructions For Use, Section 3 Preparing for an Exam under Preferences, as well as Section 5 Summary of Scanning Workflows under Scan Workflow). Enabling this option will avoid the issue. After enabling the above referenced option, you may continue to use your system(s) in accordance wit |
| Quantity | 56 units |
| Distribution | Nationwide Foreign: Austria Belgium Canada China Estonia France Germany Hondorus India Italy Mexico Netherlands Philippines Poland Singapore Spain Switzerland Taiwan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K171850 | Philips CT Big Bore Philips Medical Systems (Cleveland), Inc., Nov 9, 2017 |